Sumatriptan 50mg Tablets
Information for the user
ALMUS
Sumatriptan 50 mg Tablets
Read all of this lealet carefully because it contains important information for you.
This medicine is available without prescription to relieve migraine.
However, you still need to take it carefully to get the best results from it.
• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice
What this medicine is for
This medicine contains Sumatriptan which belongs to a group of medicines called 5HT1 agonists (‘triptans’), which act to reduce the swelling of blood vessels in the head.
It can be used to relieve migraine attacks that happen with or without warning signs (‘aura’), such as sensitivity to light, feeling sick and being sick, in people who have previously been diagnosed with migraine.
This medicine does not prevent a migraine attack, and should therefore only be taken once the migraine has started.
Before you take this medicine
This medicine can be taken by adults between the ages of 18 and 65 years. However some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
*Do not take:
• If you have not been diagnosed with migraine by a doctor or pharmacist
• If you are allergic to any of the ingredients (see ‘What is in this medicine’) or sulphonamide antibiotics
• If you are trying to prevent a migraine attack
• If you have had a heart attack, stroke or mini stroke
• If you have any of these heart or blood vessel problems:
- Blocked blood vessels
- Angina
- Unusual heart rhythm
- High blood pressure
- Poor circulation which causes cold hands and feet
• If you have liver or kidney problems
• If you have epilepsy or are prone to fits
• If you are taking the following medicines:
- Ergotamine or methylsergide (for migraine)
- Other 5HT1 agonists (‘triptans’) for migraine
• If you are taking monoamine oxidase inhibitors (for depression), or have taken them within the last 14 days
• If you have been told by your doctor that you have a rare form of migraine such as hemiplegic, basilar or opthalmoplegic migraine
• If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose)
• If you are pregnant or breastfeeding, unless your doctor tells you to !Talk to your pharmacist or doctor:
1
• If your headaches normally last for more than 24 hours
• If your normal pattern of migraine symptoms has changed
• If your attacks are more frequent, last longer or are more severe
• If you don’t fully recover from your attacks
• If you have four or more migraine attacks each month
• If you are over 50 years and this is the first time you are experiencing migraine symptoms
• If your symptoms include weakness on one side of your body, double vision, clumsy movements, ringing in the ears, reduced level of consciousness, fit-like movements, a recent rash with a headache
• If you are a woman who has had the menopause, or a man over 40 years
• If you have high cholesterol
• If you smoke regularly or use Nicotine Replacement Therapy (NRT)
• If you are very overweight
• If you have diabetes or a family history of early heart disease Other important infomation
Driving and using machines: This medicine or your migraine may make you feel sleepy. You should not drive or use machines until you are sure you are not affected.
If you have blood tests tell your doctor that you are taking this medicine.
If you take other medicines
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
• Medicines for depression
• Products containing St John’s Wort
• The contraceptive “pill”
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.
^How to take this medicine
Check the foil is not broken before use.
If it is, do not take that tablet.
|
Age |
How many to take |
How often to take |
|
Adults aged 18 to 65 years |
One tablet |
As soon as possible after the first signs of a migraine. If your symptoms go away and come back, you can take another tablet after 2 hours, Don’t take more than 2 tablets in 24 hours. |
If you do not get any relief from the first tablet do not take a second tablet for the same attack.
Swallow the tablet whole with water.
Do not give to children under 18 years.
Do not take if you are over 65 years.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
! If you take too many tablets: Go to your nearest hospital casualty department or talk to a doctor straight away. Take your medicine and this leaflet with you.
Possible side effects
Most people will not have problems, but some may get some.
!if you get any of these serious side effects, stop taking the tablets.
See a doctor at once:
• Skin rash, difficulty breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• Fits
• Heart problems including chest pain and heart attack
• Poor circulation in your hands and feet which may cause pale blue skin in your fingers and toes
These other effects are less serious. If they bother you talk to a pharmacist:
• Tingling, dizziness, feeling sleepy, decreased sensitivity (particularly to touch)
• Rapid and uncontrollable movement of the eyes, visual disturbance
• Fast, slow or irregular heart beat
• High or low blood pressure, flushing
• Feeling sick or being sick
• Feeling heavy, weak or very tired
• Feeling worried or afraid
• Stiff neck
• Pain in the joints or muscles
• Abdominal pain and bloody stools
• Diarrhoea
• Increased sweating
• heaviness, pressure, tightness or pain in the chest, throat or other parts of the body or feelings of tingling, cold or warmth- this may happen within 30 minutes of taking a tablet and should last for less than 2 hours
• Shaking
• Abnormal muscle rigidity
• Shortness of breath
• Liver function changes
If you have a blood test to check your liver function, tell your doctor or nurse that you are taking this medicine
• Heart function changes.
If you have an ECG to check your heart function, tell your doctor The medicine may change result of liver function tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
How to store this medicine
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton.
What is in this medicine
Each film-coated tablet contains Sumatriptan 50 mg, which is the active ingredient.
As well as the active ingredient, the tablets also contain lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate. The tablet coating contains Opadry peach (containing hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol, glycerol triacetate, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)).
The pack contains 2 peach oblong-shaped tablets marked with ‘5’ and ‘0’ on one side and a score line on each side.
Who makes this medicine
MA Holder: TEVA UK Limited Eastbourne BN22 9AG
Leaflet prepared June 2015
Information on migraine
Most migraine attacks occur for no apparent reason. However, something may trigger migraine attacks in some people. Triggers can be all sorts of things. For example:
Diet: Dieting too fast, irregular meals, cheese, chocolate, red wines, citrus fruits.
Environmental: Smoking and smoky rooms, glaring light, VDU screens or flickering TV sets, loud noises, strong smells.
Psychological: Stress, anxiety, anger, tirdness, etc.
Other: Periods (menstruation), shift work, different sleep patterns, the menopause, some medicines e.g. the Pill.
It may help if you keep a migraine diary.
Note down when and where each migraine attack started, what you were doing, and what you had eaten that day. A pattern may emerge, and it may be possible to avoid one or more things that may trigger your migraine attacks.
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V 1.3.1 pil-uk-pl-00289-0586-sumatriptan-50mg-tablets-almus
Approvals
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Signed by |
Meaning of Signature |
Server Date |
|
Darryl Hill |
Regulatory Affairs Approval |
19-Aug-2015 02:31:18 PM |
REG0075798 Version 1.7 Approved Page 5 of 5